PMID- 32579537 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200928 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 9 IP - 8 DP - 2020 Aug 17 TI - Development of an International, Multicenter, Hyperbaric Oxygen Treatment Registry and Research Consortium: Protocol for Outcome Data Collection and Analysis. PG - e18857 LID - 10.2196/18857 [doi] LID - e18857 AB - BACKGROUND: Hyperbaric oxygen (HBO(2))-oxygen at pressures higher than atmospheric-is approved for 14 indications by the Undersea and Hyperbaric Medical Society. HBO(2)'s main effect is to increase oxygen content in plasma and body tissues, which can counteract hypoxia or ischemia. Laboratory studies show that HBO(2) has effects beyond relieving hypoxia (eg, promoting angiogenesis in irradiated tissue, anti-inflammatory effects, radiosensitization of tumors, hypoxia preconditioning, and fungal growth inhibition) and has potential to treat conditions such as inflammatory bowel disease and pyoderma gangrenosum. Lack of consistently collected outcome data on a large cohort of individuals receiving HBO(2) therapy limits its use for both established and new indications. A course of therapy often involves 30-40 visits to a hyperbaric chamber, so the number of patients seen at any given center is constrained by chamber capacity. As a result, published HBO(2) outcome data tend to be from small case series because few patients with a particular condition are treated at a given center. To solve this problem, a registry that collects and pools data systematically from multiple institutions has been established. OBJECTIVE: The aim of this study is to collect consistent outcome data across multiple hyperbaric centers to assess treatment effectiveness and establish a research consortium. METHODS: A consortium of hyperbaric centers who have agreed to collect consistent outcome data on all patients seen has been assembled. Data are collected at each participating center using Research Electronic Data Capture (REDCap), a web-based, data collection system used frequently for research. Standard outcome measures have been defined for each condition, which are programmed into the REDCap data collection templates. Governance is through a consortium agreement that defines data security, data sharing, publications, liability, and other issues. Centers obtain Institutional Review Board (IRB) and ethics approval to participate, either from their own institutions or by relying on the IRB at the coordinating center at Dartmouth College. Dissemination will occur through a yearly report and by publications based on the data in the registry. RESULTS: Early results from some common indications show significant pretreatment to posttreatment changes. Additional indications and outcome measures are being added using the procedures outlined in the consortium agreement. CONCLUSIONS: The registry collects consistent outcome information for a therapy that needs further study and a stronger evidence base. It also overcomes the challenge of collecting data from an adequate number of patients for both established and emerging indications by combining data collection from multiple centers. The data entry requirements should be within the capabilities of existing staff at any given hyperbaric center. By using REDCap, the registry can be expanded to include detailed information on particular indications and long-term follow-up on selected patients without significantly increasing the basic data entry requirements. Through the registry, a network of enrolled hyperbaric centers has been established that provides the basis for a clinical trial network. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18857. CI - (c)Nicole P Harlan, Judy A Ptak, Judy R Rees, Devin R Cowan, Abigail M Fellows, Judith A Kertis, Pamela M Hannigan, Janet L Peacock, Jay C Buckey. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.08.2020. FAU - Harlan, Nicole P AU - Harlan NP AUID- ORCID: 0000-0002-0803-290X AD - Center for Hyperbaric Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States. FAU - Ptak, Judy A AU - Ptak JA AUID- ORCID: 0000-0002-5379-5199 AD - Center for Hyperbaric Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States. FAU - Rees, Judy R AU - Rees JR AUID- ORCID: 0000-0002-8232-1056 AD - Space Medicine Innovations Laboratory, Center for Hyperbaric Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States. FAU - Cowan, Devin R AU - Cowan DR AUID- ORCID: 0000-0003-4621-0559 AD - Space Medicine Innovations Laboratory, Center for Hyperbaric Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States. FAU - Fellows, Abigail M AU - Fellows AM AUID- ORCID: 0000-0003-2473-3578 AD - Space Medicine Innovations Laboratory, Center for Hyperbaric Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States. FAU - Kertis, Judith A AU - Kertis JA AUID- ORCID: 0000-0001-8726-3855 AD - Center for Hyperbaric Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States. FAU - Hannigan, Pamela M AU - Hannigan PM AUID- ORCID: 0000-0003-1536-7932 AD - Center for Hyperbaric Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States. FAU - Peacock, Janet L AU - Peacock JL AUID- ORCID: 0000-0002-0310-2518 AD - Space Medicine Innovations Laboratory, Center for Hyperbaric Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States. FAU - Buckey, Jay C AU - Buckey JC AUID- ORCID: 0000-0003-4591-4431 AD - Space Medicine Innovations Laboratory, Center for Hyperbaric Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States. LA - eng PT - Journal Article DEP - 20200817 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC7459436 OTO - NOTNLM OT - effectiveness OT - health data OT - hyperbaric oxygenation OT - measure OT - outcome OT - oxygen treatment OT - patient reported OT - patient-reported outcome measures OT - registries OT - registry OT - treatment COIS- Conflicts of Interest: None declared. EDAT- 2020/06/25 06:00 MHDA- 2020/06/25 06:01 PMCR- 2020/08/17 CRDT- 2020/06/25 06:00 PHST- 2020/03/23 00:00 [received] PHST- 2020/06/23 00:00 [accepted] PHST- 2020/06/19 00:00 [revised] PHST- 2020/06/25 06:00 [pubmed] PHST- 2020/06/25 06:01 [medline] PHST- 2020/06/25 06:00 [entrez] PHST- 2020/08/17 00:00 [pmc-release] AID - v9i8e18857 [pii] AID - 10.2196/18857 [doi] PST - epublish SO - JMIR Res Protoc. 2020 Aug 17;9(8):e18857. doi: 10.2196/18857.